Knotless filament anchor for soft tissue repair

ABSTRACT

In one embodiment, the present invention includes a method for securing tissue to bone, including drilling a bone hole into the bone; passing a filament through the tissue, the filament including a first end, a second end and a length therebetween, the second end having a loop; passing the first end of the filament through the loop of the filament; pulling on the first end of the filament such that the loop travels along the length of the filament and to the tissue; passing an anchor along the length of the filament, from the first end towards the loop and tissue; engaging the loop with a distal end of the anchor; positioning the distal end of the anchor, with the loop of the filament, into the bone hole; and securing the anchor in the bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 14/308,208, filed Jun. 18, 2014, which is a continuation of U.S.patent application Ser. No. 13/441,290, filed Apr. 6, 2012, thedisclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

Various shoulder injuries may result from dislocations and otherinjuries resulting from traumatic events such as falling or blunt force,or from repetitive motions such as throwing or lifting. A commonshoulder injury includes the separation of the glenoid labrum from theglenoid. For example, a Bankart lesion results from a labrum tear thatoccurs in the anterioinferior region of the glenoid socket when theshoulder dislocates. A superior labrum anterior posterior (SLAP) lesiontypically occurs from throwing injuries, where the tear occurs at thesuperior region of the glenoid socket where the biceps tendon attachesto the shoulder. These injuries result in pain and instability of theshoulder joints.

Arthroscopic stabilization for surgical treatment of shoulderinstability has grown in popularity over the past decade. In particular,tissue anchors have been employed to repair torn labrum tissue. Forexample, a tissue anchor may be inserted into the glenoid, and a suturematerial that is attached to the anchor is used to reattach the tornlabrum tissue to the glenoid.

Tissue anchors have similarly been used in other tissue repairprocedures directed towards the rotator cuff, labrum tissue of the hip,and the like. Similar to the labrum repair above, such surgeriestypically include placing a tissue anchor into bone at or adjacent tothe site of tissue attachment (commonly at or adjacent to the nativeattachment site) and utilizing a suture to draw the tissue to bereattached towards the tissue anchor and thus, towards the bone. Thesuture is secured in a known fashion, such as by tying a knot, and therepair is complete.

Knotless tissue anchors have grown in popularity in recent years for usein these types of surgical procedures. Knotless tissue anchors, ascommonly defined, do not require the tying of knots by an operator(e.g., surgeon) to secure the tissue to the bone. Instead, the anchorhas another type of locking feature which secures the suture, and thusthe tissue, without the tying of knots. Such anchors have grown inpopularity due to their ease of use and simplification of the surgicalprocedure by, for example, eliminating the need for knot pusherinstruments and the like.

However, currently used “knotless” tissue anchors typically stillinclude a knot somewhere along the suture such that, even though theoperator may not be required to tie a knot during the surgicalprocedure, the suture still includes a knot, typically pre-tied by theanchor manufacturer, along its length. This knot, over time and withrepeated use, will tighten, thereby loosening the repair. In the exampleof a labrum repair, such tightening of the knot may loosen the repairsuch that the labrum is no longer positioned snugly against the bonesurface. Such loosening may occur even if the suture remains intact.

Therefore, there is room for improvement over existing “knotless”anchors, particularly with regard to, for example, furthersimplification of insertion of such anchors, as well as better assuranceof replication of the procedure. Additionally, there is a need in theart for a truly knotless tissue anchor which does not include any knots,whether pre-tied or tied by the operator, in the suture.

BRIEF SUMMARY OF THE INVENTION

In one embodiment, the present invention includes a method for securingtissue to bone, including drilling a bone hole into the bone; passing afilament through the tissue, the filament including a first end, asecond end and a length therebetween, the second end having a loop;passing the first end of the filament through the loop of the filament;pulling on the first end of the filament such that the loop travelsalong the length of the filament and to the tissue; passing an anchoralong the length of the filament, from the first end towards the loopand tissue; engaging the loop with a distal end of the anchor;positioning the distal end of the anchor, with the loop of the filament,into the bone hole; and securing the anchor in the bone.

Further, the step of drilling the bone hole further may include drillinga first portion of the bone hole to a first diameter and a secondportion of the bone hole to a second diameter, wherein the firstdiameter is smaller than the second diameter. The drill may furtherinclude a bushing, such that the step of drilling also includes the stepof marking the surface of the bone surrounding the bone hole with adistal face of the bushing. The distal face of the bushing may include amarking material. Also, the step of securing the anchor in the bone mayfurther include directing the anchor into the second portion of the bonehole and forcing the anchor through the second portion and into thefirst portion of the bone hole. The anchor may continue to be forcedinto the bone hole such that the anchor may be forced through the firstportion of the bone hole and further into the bone past the firstportion of the bone hole. Moreover, the anchor may be engaged with aninserter with which an operator performs the steps of passing the anchortowards the loop and tissue, positioning the distal end of the anchorinto the bone hole, and securing the anchor in the bone. The method mayfurther include positioning a cannulated guide adjacent to the tissueand bone, such that the steps of the above method, including for examplethe drilling, passing and positioning steps, may be performed at leastpartially through the cannulated guide.

In another embodiment, the present invention may include a system forsecuring tissue to bone, including a drill; a filament having a firstend and a second end, the second end including a loop; and an anchorhaving a distal end and a proximal end, wherein the distal end iscapable of engaging the loop of the filament.

The drill may include a boring structure, on a distal end of the drill,having a first diameter at a distal end and a second diameter proximalof the first diameter, wherein the second diameter is larger than thefirst diameter. The anchor has a diameter, wherein the diameter of theanchor may be larger than the first diameter of the drill andsubstantially the same size as the second diameter. Alternatively, thediameter of the anchor may be smaller than the second diameter. Thesystem may further include an inserter adapted to engage the anchor atthe proximal end. Further, the anchor may be cannulated and the insertermay be at least partially cannulated, such that the cannulated anchorand inserter are adapted to position a portion of the first end of thefilament therein.

In yet another embodiment, the present invention may include a drillhaving a boring structure having a first diameter at a distal end and asecond diameter proximal of the first diameter, wherein the seconddiameter is larger than the first diameter. The drill may furtherinclude at least one flute at the distal end, having the first diameter,and another at least one flute having the second diameter, positionedproximal to the at least one flute at the distal end. The drill may alsoinclude a shaft, proximal to the boring structure, wherein the shaft mayinclude a flexible portion.

In a further embodiment, the present invention may include a drillhaving a distal boring structure and a shaft proximal to the distalboring structure, and a bushing positioned on the shaft proximal to thedistal boring structure. The bushing may further include a distal face,wherein at least a portion of the distal face is exposed around at leasta portion of the distal boring structure. The distal face may include amarking material positioned thereon adapted to mark a surface of thebone. The surface of the bone may include the bone surface surrounding aprepared bone hole prepared by the distal boring structure. Further, thebushing may be adapted to prevent the drill from creating a bone holehaving a depth greater than a length measured from the distal-mostportion of the distal boring structure to the distal face of thebushing.

In another embodiment, the present invention may include a filamenthaving a length between a first end and a second end, the second endincluding a loop, and at least a portion of the filament having aconstruction including a substantially solid thickness. For example, atleast a portion of the loop may include a substantially solid thickness(e.g., monofilament structure). Alternatively, at least a portion of thelength between the first and second ends may include a substantiallysolid thickness.

In yet a further embodiment, the present invention may include afilament having a length between a first end and a second end, thesecond end including a loop, the filament also including at least onemarking along its length. The marking may be located on at least aportion of the loop. Alternatively, the marking may be located on atleast a portion of the length between the first and second ends.Additionally, multiple markings may be positioned at various locationson the filament. The markings may include, for example, a spot, a radialring, a portion having a differing color from the rest of the filament,or the like.

In another embodiment, the present invention may include a method ofrepairing tissue, including passing a first filament through the tissueat a first location, the filament including a length between a first endand a second end, the second end including a loop; passing the first endof the filament through the loop and tensioning the first end; preparinga first bone hole at a location in bone adjacent to the tissue,tensioning the first end of the filament in the direction of the bonehole; and securing the first end of the filament at the bone hole usinga first suture anchor. The method is performed without the tying of anyknots.

The method may further include passing a second filament through thetissue at a second location, the filament including a length between afirst end and a second end, the second end including a loop; passing thefirst end of the second filament through the loop and tensioning thefirst end; preparing a second bone hole at a second location in boneadjacent to the tissue, tensioning the first end of the second filamentin the direction of the second bone hole; and securing the first end ofthe filament at the second bone hole using a second suture anchor.Alternatively, the second filament may be secured at the first bone holeusing the first anchor, such that a second bone hole and second sutureanchor is not necessary. The tissue may be a rotator cuff, such that thefirst bone hole and optional second bone hole are positioned lateral tothe rotator cuff tissue.

In yet another embodiment, the present invention may include a method ofrepairing tissue including passing a first tail of a first filamentthrough the tissue at a first location, the filament including at leasttwo tails, each tail having a length between a first end and a secondend, the second end of each tail ending at a common loop; passing thefirst end of the first tail through the loop and tensioning the firstend; preparing a first bone hole at a location in bone adjacent to thetissue, tensioning the first end of the first tail in the direction ofthe bone hole; and securing the first tail of the filament at the bonehole using a first suture anchor; passing a first tail of a secondfilament through the tissue at a second location, the second filamentincluding at least two tails, each tail having a length between a firstend and a second end, the second end of each tail ending at a commonloop of the second filament; passing the first end of the first tail ofthe second filament through the loop of the second filament andtensioning the first end; preparing a second bone hole at a location inbone adjacent to the tissue; tensioning the first end of the first tailof the second filament in the direction of the second bone hole; andsecuring the first tail of the filament at the second bone hole using asecond suture anchor; tensioning the second tails of both the first andsecond filaments; preparing a third bone hole at a location in boneadjacent to the tissue; tensioning the first ends of the second tails ofthe first and second filaments in the direction of the third bone hole;and securing the second tails of the first and second filaments at thethird bone hole using a third suture anchor. This method is performedwithout the tying of any knots. The first tail and the loop of eachfilament may substantially surround a portion of tissue. The tissue maybe a rotator cuff, and more specifically a torn rotator cuff to bereattached to the bone. The first, second and third bone holes may bepositioned laterally relative to the rotator cuff tissue. The method mayalso include, during the step of tensioning the first ends of the firsttails of the first and second filaments, tensioning the tissue in thedirection of the tensioning.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates one embodiment of the tissue anchor of the presentinvention.

FIG. 2 illustrates a second view of the tissue anchor of FIG. 1.

FIG. 3 illustrates a detailed view of a distal end of the tissue anchorof FIGS. 1 and 2.

FIG. 4 illustrates one embodiment of the filament of the presentinvention.

FIG. 5 illustrates another embodiment of the filament of the presentinvention.

FIG. 6 illustrates one embodiment of the drill of the present invention.

FIG. 6A illustrates a detailed view of the distal end the drill of FIG.6.

FIGS. 7A and 7B illustrate another embodiment of the drill of thepresent invention, with FIG. 7B also illustrating the drill with abushing.

FIGS. 8A-8L illustrate various steps of one embodiment of a method ofthe present invention as exemplified using a model bone block.

FIGS. 9A-C illustrate various steps of another embodiment of a method ofthe present invention.

FIGS. 10A and 10B illustrate various steps of another embodiment of amethod of the present invention.

FIGS. 11A and 11B illustrate various steps of another embodiment of amethod of the present invention.

DETAILED DESCRIPTION

The present invention is directed towards a tissue anchor and namely, atissue anchor for securing tissue to bone. The various embodimentsherein are directed towards the use of the tissue anchor for repairing ashoulder labrum, through reattachment of the labrum to the bone at oradjacent to its native attachment site. However, the tissue anchors,methods, systems, and kits of the present invention may be used in therepair of tissues other than the labrum, including, for example, rotatorcuff tissue. Other cartilage, ligament, tendons and other such softtissues may also be repaired by the present invention. The presentinvention may be used in both arthroscopic and open surgical procedures,though its benefits are perhaps most apparent in arthroscopicapplications. Further, the present invention is intended to becompletely knotless, such that no knots, whether pre-tied by themanufacturer or tied by the operator (e.g., surgeon) during a surgicalprocedure, are required along the suture (or other filament used) at anypoint during the surgical procedure. However, of course, individualoperator preference may be such that an operator may incorporate a knotin the suture, despite the present invention being capable of performingthe surgical procedure without the incorporation of knots.

Throughout this application, “proximal” or “proximally” is intended tomean closer to the operator or towards the operator, while “distal” or“distally” is intended to mean further from the operator or away fromthe operator.

In one embodiment, the present invention may include an anchor 10 havinga distal end 11 and a proximal end 16, as illustrated in FIGS. 1 and 2.The distal end includes tips 12 a, 12 b and a saddle 13. The anchor 10also has a length between the distal end and the proximal end and anouter surface along the length. Along at least a portion of the outersurface is at least one groove 14 and at least one ridge 15. The anchormay also have a cannula 17 along at least a portion of its length or,preferably, its entire length. The proximal end 16 may include astructure suitable for engagement by an inserter instrument, such as anindentation from the proximal end 16 through at least a portion of thelength of the anchor. Such indentation may include a shape, such as ahexagonal shape, which may match a similar shape on the inserterinstrument. Alternatively, in the example of a fully cannulated anchor10, the structure for engagement by the inserter instrument may bepositioned on the proximal end 16 of the anchor 10 between the outersurface and the cannula 17.

FIG. 3 illustrates the distal end 11 of the embodiment of FIGS. 1 and 2.The distal end 11 is shaped to accommodate a filament thereon, forexample, on saddle 13. Further, the tips 12 a, 12 b are shaped to atleast engage bone, though at least one tip may also be shaped to engagethe filament. In this embodiment, the tips 12 a, 12 b both have agenerally triangular shape which may provide a self-tapping orself-boring aspect to the anchor 10 upon insertion of the anchor intothe bone. Further, such a shape may also allow at least one tip toengage the filament, such as by piercing or otherwise catching thefilament.

The anchor 10 may have a sufficient size for use in an intended surgicalprocedure such that it provides sufficient pullout strength to therepair while being able to pass through instrumentation, such as acannulated guide (discussed below). Moreover, the anchor 10 may be of asufficiently small size to allow for a surgical site of reduced size,including a smaller diameter bone hole than is commonly used in suchsurgeries. In one example, the anchor 10 may be about 10 mm in length,with a diameter, from ridge 15 to ridge 15, of from about 2 mm to about4 mm, and specifically between about 2.75 mm to about 3.75 mm, and morespecifically about 3.50 mm. The length and diameter dimensions dependon, for example, the intended use and anatomical location of the anchor,and thus other dimensions are also envisioned. For example, if theanchor 10 is used for tissue repair in smaller joints, such as in theankle, foot or hand, then the dimensions would be significantly smallerthan those described above. The saddle 13, between tips 12 a, 12 b maybe dimensioned to accommodate a filament therein, and as such the widthof the saddle may be dependent on the size of filament to be positionedon the saddle. For example, the saddle may have a width of less than 1mm, and more specifically about 0.80 mm, to accommodate a filamenthaving a similarly sized diameter.

The anchor 10 may be constructed from any material suitable forimplantation into the body, including, for example, metal, such astitanium, or polymer, such a PEEK.

This embodiment may also include filament 20, as illustrated in FIG. 4,which includes a first end 21 and a second end 22, where the second endmay further include a loop 23. The portion of the first and second ends,extending from loop 23, forms a length of filament, or a tail. Thefilament may be of any material, such as a suture or the like, suitablefor use in surgical and namely orthopedic applications. The first end 21may include a portion treated such that it is less flexible that therest of the filament 20. For example, a portion of the first end 21,extending from the end of the filament and along a certain length offilament from the end, may have a greater stiffness than the remainderof the length of the filament 20. Such a stiff end may be useful, asdiscussed below, in assisting the operator in threading the first end 21through the cannulated anchor 10, a cannulated instrument, or the like.The filament may be sized such that a portion of the filament, such asloop 23, may be accommodated within the saddle 13 of anchor 10.

The loop 23 may be woven during manufacture of the filament 20, suchthat a knot is not required to form the loop 23. Weaving the loop, forexample, may eliminate an area of weakness (such as when a knot is usedto form a loop) and thus may limit lengthening of the suture duringsubsequent use by the patient of the repaired tissue. Thus, loop 23 maycontribute to increased success of the surgical procedure through theuse of the present invention. The size of the loop may vary, dependingupon its intended application and/or anatomical location. For example,in some embodiments, the loop may have a diameter of at least about 2mm. This diameter may be in the range of from about 2 mm to about 25 mm,though larger and smaller sized loops may also be used for particularapplications. In some examples, the loop 23 may be about 2 mm, about 10mm, or about 25 mm, or other sizes in between.

In an alternative embodiment, as illustrated in FIG. 5, the filament 120may include, extending from the loop 123, two discrete lengths offilament, or tails, extending from second ends 122 a, 122 b adjacent tothe loop and each terminating to a first end 121 a, 121 b, respectively.Of course, filaments including multiple discrete lengths, and multipleloops, are also envisioned. These discrete lengths may be useful in somemethod embodiments where, for example, multiple anchors and/or multipletissues are involved. Examples of such methods are discussed below.

In yet another embodiment, at least a portion of the filament 20, 120may include an at least one indicating marker (not shown) along itslength. Such markings may be similar to those disclosed in co-pendingU.S. application Ser. No. 13/303,849, filed Nov. 23, 2011, the entiretyof which is incorporated by reference herein as if fully set forthherein. For example, such indicating marker may be, for example, a spot,a radial ring, a portion having a differing color from the rest of thefilament, or the like. In another example, the indicating marker may bea portion of the filament 20, 120 being of a different color than therest of the filament. Such contrasting colors of these portions mayprovide a clear indication to the operator when performing a surgicalprocedure, and may be of particular use in arthroscopic procedures. Inanother example, using filament 120, the first tail (121 a, 122 a) maybe one color and the second tail (121 b, 122 b) may be a different colorfrom the first tail such that the operator may easily distinguishbetween the two. In yet another example, the loop 23, 123 of filament20, 120 may have a marking which may be used by the operator to ensure asufficient amount of the loop 23, 123 is around the tissue to providefor adequate fixation of the tissue. In this example, the marking may behidden from the operator, once the loop is in the luggage-tagconfiguration, which would notify the operator that a sufficient amountof tissue has been grasped within the loop. However, if the marking canstill be seen by the operator (when the loop is in the luggage tagconfiguration), that may indicate to the operator that too little tissuehas been grasped within the loop, and thus that the operator shouldrepeat that step. Of course, other variations of such markings may alsobe used.

Moreover, in yet another embodiment, the filament 20, 120 of the presentinvention may also include at least a portion of its length having amonofilament structure. For example, the monofilament structure isessentially a portion of the filament which does not have a hollow core,as is typical of most surgical filaments, such as suture. Instead, thehollow core is filled with additional strands of filament to create asubstantially solid filament. In one example, the loop 23, 123 mayinclude such a monofilament structure. Alternatively, a portion of thetail, or tails, may also include a monofilament structure along at leasta portion of its length.

FIGS. 6 and 6A illustrate one embodiment of a drill 50 having a proximalend 51 and a distal end 55 and a length of shaft 52 therebetween. Thedrill may be either reusable or disposable. The drill may bemanufactured of stainless steel, nitinol, or other biocompatiblematerial.

The distal end 55 of drill 50 constitutes a boring structure whichincludes a first portion 56 having a first diameter and a second portion58 having a second diameter. Both first and second portions include atleast one flute 57, 59 (respectively) shaped and dimensioned to create ahole in bone. This configuration of the distal end 55 may create a“stepped” bone hole, in that the bone hole includes, for example, adistal portion having a diameter substantially equal to the firstdiameter of the first portion 56 and a proximal portion having adiameter substantially equal to the second diameter of the secondportion 58. In one example, such a bone hole preparation may result inthe proximal portion being positioned within substantially the entiredepth of the cortical bone, such that the second portion 58 of the drill50 decorticates the bone hole site, while the distal portion of the bonehole is positioned substantially within the underlying cancellous bone,such that the first portion 56 of the drill 50 forms a pilot holethrough the cancellous bone to a depth substantially equal to the lengthof the first portion 56. As discussed below, this pilot hole is onlydrilled to a partial depth relative to the final depth of the implantedanchor in the bone. This example may result in a bone hole including adecorticated area and a pilot hole into the cancellous bone, though insome surgical sites, where the cortical bone may be thinner than normal,the second portion 58 of the drill may form a hole extending through thecortical bone and into a portion of the cancellous bone.

To further this example, the first and second portions 56, 58 of drill50 are sized to prepare such a bone hole. Thus, in this example, thelength of the first portion 56 may be about 6 mm, and the length of thesecond portion may be about 3 mm. In an alternative example, the lengthof the first portion may be about 4 mm, and the length of the secondportion may be about 4 mm. While the length of the second portion shouldbe sufficient to decorticate the entire depth of the cortical bone atthe surgical site, the length of the first portion may have any lengthdesired and may be designed with a specific surgical procedure in mindor, alternatively, may be a fixed length which is suitable for mostintended surgical procedures.

The first and second diameters of the first and second portions 56, 58of drill 50 may also vary dependent upon, for example, the size of thetissue anchor to be positioned and secured within the bone hole. Thefirst portion 56 may include a diameter which is smaller than thediameter of the tissue anchor to be implanted within the bone hole, thusforming a pilot hole relative to the anchor to be implanted. Using theabove dimensions for anchor 10 as a reference point for this example,the first diameter of the first portion 56 of the drill 50 would be lessthan, for example, 3.50 mm, and specifically, less than about 2 mm, andmore specifically, about 1.5 mm. The second diameter, of the secondportion 58, again using anchor 10 as a reference, would be at leastabout 3.50 mm, and specifically about 3.70 mm.

The proximal end 51 may include a structure for connection to a powerdrill, a hand drill, or the like, to rotate the distal end 55.

The shaft 52 of drill 50 may have a diameter, and structure, sufficientto transfer the rotational force from the proximal end 51 to the distalend 55. Thus, for example, the shaft 52, along with the proximal anddistal ends, may be manufactured out of metal, such as stainless steelor the like, or other material suitable for a drill used to prepare abone hole. The diameter of the shaft may be larger than the distal end55, such as about 4.0 mm, though the shaft should not be too large as tonot fit through instrumentation being used, such as a cannula or drillguide.

In another embodiment, the shaft 52 may be flexible such that the drillmay pass through a curved cannulated guide or curved drill guide. Suchexemplary instrumentation is disclosed in U.S. patent application Ser.No. 12/821,504, filed Jun. 23, 2010, the entirety of which isincorporated by reference herein as if fully set forth herein, as wellas in the TwinLoop FLEX Instrumentation System (Stryker Endoscopy, SanJose, Calif.).

In an alternative embodiment of the drill of the present invention,drill 150 is illustrated in FIGS. 7A-7B. Drill 150 is similar to drill50 in that a similar bone hole is prepared by either drill. Asillustrated in FIGS. 7A, 7B, the distal end 155 constitutes a boringstructure, similar to that of FIG. 6A, which includes a first portion156 having a first diameter and a second portion 158 having a seconddiameter. Both first and second portions include at least one flute 157,159 (respectively) shaped and dimensioned to create a hole in bone. Thisconfiguration of the distal end 155 also creates the “stepped” bonehole, including, for example, a distal portion having a diametersubstantially equal to the first diameter of the first portion 156 and aproximal portion having a diameter substantially equal to the seconddiameter of the second portion 158.

Drill 150, however, includes a shaft 152 having a stepped portion 153 ofa larger diameter than the rest of the length of the shaft. Steppedportion 153 may have a diameter substantially equal to or greater thanthe second portion 158 which may, for example, ensure that the distalend 155 of the drill 150 remains centered within a cannulated guide, ordrill guide, if one is used. Stepped portion may also include acircumferential groove 154 within which a bushing 160 may be positioned.

Bushing 160 may be positioned within groove 154 and may be held in placeby the shape of the groove 154, an adhesive, or the like. Bushing mayrotate along with the drill or may be capable of rotation independent ofthe drill such that, for example, bushing 160 may remain in a stationaryposition even while the drill is rotating during use. Bushing may bemanufactured of plastic or other biocompatible material, such as forexample, PEEK. Bushing 160 may also assist in maintaining the drill 150in a centered position within a cannulated guide, or drill guide.Bushing 160 may have a diameter that is substantially equal to thestepped portion 153 to maintain a smooth, generally continuous surfacealong the shaft. Furthermore, the bushing 160 may serve as a visualindicator for the operator to determine the depth of the drill in thebone. For example, the bushing may have a different color than the drillshaft, such that the contrasting colors serve as the visual indicator tothe operator. Of course, even with the contrasting colors, the shaft maystill include a laser marking (e.g., proximal to the bushing), which mayserve as an additional visual indicator.

Additionally, bushing 160 may include a distal face 165, at least aportion of which is exposed, as illustrated in FIG. 7B. If bushing is tobe used with drill 150, as in FIG. 7B, the distal end 155 may benarrowed in at least one dimension, such that as much of the distal face165 is exposed as possible. Such narrowing of the distal end 155, in oneexample, may result in the flatter-shaped distal end illustrated inFIGS. 7A and 7B as opposed to the generally circular-shaped distal end55 of the drill 50 of FIGS. 6 and 6A. This distal face 165 may serve asa drill stop to prevent the distal end 155 from proceeding too deeplyinto the bone. Distal face 165 may also include a marking materialapplied to its surface. The marking material may be surgical ink, or thelike, which, upon contact with the bone surface (surrounding theprepared bone hole), marks the contacted bone surface with the ink. Inuse, this marking may assist the operator in locating the bone hole forinsertion of the bone anchor 10 (other other anchor). Such marking maybe particularly useful in methods of surgery where, for example, thedrill is used to create multiple bone holes, or where the bone hole isprepared in an anatomical position difficult to access, such as forexample a position under a rotator cuff tissue, or the like.

The bushing 160 may be easily removable from the drill such that thedrill may be reused and, each subsequent use, a new bushing may beinstalled on the groove 154. Alternatively, if the drill is disposable,then the bushing may be positioned on the drill during manufacture(using an adhesive or the like) and, upon using the drill, the operatormay dispose of the entire structure. Of course, bushing 165 may alsohave sufficient marking material on its distal face 165 for multiplesurgeries.

In another embodiment, the present invention may include a systemincluding a tissue anchor, a filament and a drill. Such a system may besupplied to the operator in various ways. For example, the drill may besterilizable and reusable, and thus only the anchor and filament need besupplied for each particular surgical procedure. In this example, thefilament and anchor may be sold separately or together as a set. Thesystem may also include a cannulated guide (or drill guide) and aninserter for insertion of the tissue anchor. Thus, in another example,the system may include the anchor, filament, and inserter, andoptionally, the drill and/or cannulated guide (or drill guide).

In yet another embodiment, the present invention may also include a kitincluding at least one anchor and at least one filament. For example, ananchor may be sold with a plurality of filaments such that the operatormay determine the appropriate filament for a particular surgicalprocedure. The plurality of filaments may differ according to, forexample, diameter of the filament, length of the tail (or tails) of thefilament, size of the loop, number of discrete filament portions ortails extending from the loop, number of loops on the filament, colorand/or texture, and the like. In an alternative example, the kit mayinclude a plurality of anchors 10 which may differ according to length,diameter, size of saddle, number and/or shape of the tips, and the like.Alternatively, other anchors (such as those included in the belowsurgical methods) may be included in such kits with the filament 20, 120or filaments. Such kits may provide the operator with a selection ofoptions which may be utilized for a particular surgical procedure and/orcertain anatomical constraints. Such kits of the present invention mayalso include any or all of at least one inserter, at least one drill, atleast one cannulated guide (or drill guide), or the like. In oneexample, the kit may also include a plurality of cannulated guideshaving various angles of curvature for use in various anatomicallocations which may be better suited to using curved instrumentation. Ofcourse, such kits may also include a cannulated guide that is linear orstraight.

The devices, systems and kits of the present invention may be used invarious methods of surgery. As discussed above, the below methods arespecific to labrum repair or rotator cuff repair in the shoulder, thoughsuch methods are also applicable to, for example, labrum repair in thehip as well as the repair of other soft tissues. The devices, systemsand kits, having smaller dimensions than those discussed above, may alsobe used in small joint surgical methods and procedures, such as ankle,hand and foot soft tissue repairs. Moreover, these methods of surgeryare described as to arthroscopic repair, though other forms of surgery,such as open surgery, are also envisioned.

In one embodiment, illustrated in FIGS. 8A-L, a method of the presentinvention may be used to secure tissue 80 to bone 70, for example, torepair a tear in the labrum to reattach the labrum to the bone at oradjacent to the native attachment site. Upon accessing the surgical site(e.g., the labrum tear from the glenoid), a cannulated guide (such asany of the “guides” 12, 14, 16, 18, 20 disclosed in U.S. patentapplication Ser. No. 12/821,504, incorporated by reference above, thoughof course an additional, outer surgical cannula, as is well known forarthroscopic procedures, may also be present outside of such “guides”)is optionally positioned through the opening in the surface tissues suchthat a distal end of the cannulated guide may be positioned adjacent tothe surgical site. A drill, such as those illustrated in FIGS. 6-7, isthen passed through the cannulated guide (if present) until the distalend 55 of the drill is positioned adjacent to the area of the glenoid(bone 70) where the labrum (tissue 80) will be reattached. The bone hole75 is then formed using the drill (FIG. 8E). The drill optionallyincludes a laser mark (not shown), or the like, such that the operatorcan drill to a proper, predetermined depth. Alternatively, the drill mayhave a physical stop (not shown), such as at the proximal-most end ofthe shaft 52, which abuts against the proximal-most end of thecannulated guide and prevents the operator from drilling into the boneany further than the length of the distal end 55. Bushing 160 (FIG. 7B)may also serve as the physical stop. Upon completion of the bone hole75, the drill is removed from the cannulated guide. A filament 20, suchas is illustrated in FIG. 4, is then passed through the cannulated guide(if present) to the detached labrum 80, and the filament is passedaround the labrum using known means (FIG. 8A). If using the filament ofFIG. 4, either of the first end 21 or the second end 22, having loop 23,may be passed around the labrum 80. In an alternative, the cannulatedguide, if used during the preparation of the bone hole, may be removedprior to the step of passing the filament 20 to and around the labrumtissue. In another alternative, rather than the filament 20 passingaround the soft tissue 80, the filament may alternatively be passedthrough the tissue 80. Passing the filament 20 through the tissue 80 mayhave the benefit of maintaining separation between the filament 20 andthe articulating surface of the shoulder joint.

With the filament 20 now positioned on the labrum 80 (FIG. 8A, eitheraround the labrum as shown or through the labrum), the filament may bemaneuvered such that both the first and second ends are outside the bodyof the patient (and the cannulated guide, if present), in the proximaldirection, such that the operator may pass the first end 21 through theloop 23 of the second end 22 (FIG. 8B). Of course, if this can beaccomplished at the surgical site without trouble, this step mayalternatively be performed at the surgical site or even within thecannlated guide (if present). The first end 21, once through loop 23,may then be pulled such that loop 23 travels along the length of thefilament and to the labrum tissue 80 (FIGS. 8C-D). The filament is nowsecured to the tissue in a “luggage tag”—type configuration (FIG. 8D).It should be noted that either the preparation of the bone hole 75 (FIG.8E) or the passing and positioning of the filament 20 onto the labrum 80(FIGS. 8A-D) may be completed first, followed by the other.

The first end 21 of filament 20 may be placed within the cannulated bodyof the anchor 10, which is engaged with an inserter 60 (FIG. 8F), andthe anchor may travel along the filament towards the second end 22. Theinserter 60 may also be cannulated along at least a portion of itslength such that the filament may pass through the anchor 10, out theproximal end of anchor 10 and into the cannulated portion of theinserter. The filament may then pass completely through the inserter, ifthe entire length of the body is cannulated, or the filament may exitthrough an opening 61 in the side of the inserter, if only a portion ofthe inserter is cannulated (as in FIG. 8F). The first end 21 may haveincreased stiffness to allow for ease of threading the anchor andinserter onto the filament. In one example, the stiffened portion of thefilament 21 may have a length sufficient to span the distance betweenthe distal end 11 of the anchor to the exit opening 61 through the sideof the inserter, which may provide for simplified threading of thefilament through the anchor and inserter. The anchor, such as anchor 10of FIGS. 1-3, engaged with inserter 60 (FIG. 8F), may now be movedtowards the surgical site (FIG. 8G). If used at all, the cannulatedguide may be removed from the surgical site prior to the step of movingthe anchor into the surgical site (though as above, it may be removedprior to passing the filament, if drilling the bore hole is performedprior to passing the filament), however, in some embodiments, the anchor10 and inserter 60 may pass through the cannulated guide and to thesurgical site.

Once the anchor is at the surgical site, the distal end 11 of the anchorengages the filament (FIG. 8G). For example, at least one of the tips 12a, 12 b may pierce the filament, such as at the intersection of the loop23 with the rest of the filament, to engage the filament. Alternatively,the distal end 11 may be maneuvered, using the inserter 60, such that aportion of the filament, such as the loop 23, is engaged by the saddle13 (as in FIG. 8G). In any event, once the distal end 11 engages thefilament, a portion of the loop 23 may be positioned within the saddle13 and another portion of the loop may be positioned within a portion ofthe groove 14 (FIGS. 8H-I).

The distal end 11 of the anchor is then directed to the bone hole 75,thereby drawing the filament 20, and secured tissue 80, to the bone holeas well (FIGS. 8H-I). Such drawing of the tissue may also tension thetissue. The distal end 11 of the anchor is then placed within the bonehole 75, and specifically within the second portion of the bone hole, asthe second portion has a sufficient diameter to accommodate the anchor(FIG. 8I). At this position, the distal end 11 of the anchor is engagedwith the wall of the bone hole 75 and is positioned against the bottomsurface of the second portion of the bone hole (at which point the bonehole steps down to the first portion having the first diameter), thoughthe remainder of the anchor is still protruding from the bone surface.Moreover, in this position, the tissue anchor, while engaged with thewall of the bone hole, may still have a weak pull-out strength such thatit may be easily removed from the bone hole, if needed, for reinsertionor repositioning.

Once in this position, the operator may, using a rubber mallet or thelike, apply a force to the inserter 60 which forces the anchor furtherinto the bone (FIG. 8J). As the anchor drives distally, into the firstportion of the bone hole (the pilot hole), the anchor bores through thecancellous bone, thereby forming a bone hole having the same diameter asthe anchor along the length of the already-formed pilot hole. Further,based on the above exemplary dimensions, the distal tip of the anchormay extend beyond the end of the first portion of the bone hole anddeeper into the cancellous bone, such that the anchor is completelyself-tapping into the cancellous bone. The operator continues applyingsuch a force to the anchor until the proximal end 16 of the anchor isflush with, or below, the surface of the bone (FIG. 8K). For example,the inserter may have a first laser mark 62 indicating that, once flushwith the outer cortical bone surface, the anchor 10 is sufficiently deepwithin the bone, though at a minimum range of such depth. The inserter60 may also include a second laser mark 63 indicating that, once flushwith the outer cortical bone surface, the anchor 10 is at a depthtowards the maximum range of sufficient depth. Thus, the operator mayforce the anchor 10 to a depth at one of the two laser marks 62, 63 orat a position between the two laser marks 62, 63 on the inserter 60. Theoperator may position the anchor 10 at a certain depth dependent uponvarious factors, including bone quality, surrounding anatomy, and thelike. Furthermore, the operator may position the anchor at a particulardepth to obtain a desired tension on the tissue 80 being secured. Forexample, if at the first laser mark 62 the tissue is still too loose,the operator may drive the anchor 10 deeper into the bone 70, towards adepth denoted by the second laser mark 63, and by doing so, the operatormay be increasing tension on the tissue 80. Thus, the depth of theanchor 10 may be adjusted to attain a desired tension on the tissue 80being secured, which may result in a better repair.

At this position, the anchor is thereby secured within the bone hole dueto the ridge or ridges 15 on the outer surface of the anchor whichassist in preventing back-out of the anchor from the bone hole. Thesurrounding cancellous bone, following the boring by the anchor, may,due to its inherent elasticity, interdigitate with the ridges, wherebythe cancellous bone may gravitate towards the anchor such thatcancellous bone fits against the surface of the anchor, in between andaround the ridges.

The anchor is now secured within the bone hole, thereby also securingthe filament in place. The loop 23 of the filament 20 remains engagedwith the distal end 11 of the anchor 10, while the remaining portion ofthe loop may be positioned within the groove 14 and out of the bonehole, where it remains engaged with the tissue, which is now positionedat or adjacent to the bone hole (FIGS. 8K-L). The remaining portion ofthe filament, extending to the first end 21, extends from the distal end11 of the anchor 10, at the intersection with loop 23, through thecannulated body of the anchor 10, and out of the surgical site. Thislength of filament may be cut (typically where the filament exits fromthe proximal end 16 of the anchor 10) and removed from the surgical site(FIG. 8L), and the cannulated guide is withdrawn and the wound is closedas is known in the art.

It should be noted that the cannulated guide is optional for thismethod. As seen in the illustrations of FIG. 8, the cannulated guide isnot present, but instead, the inserter 60 merely passes through a commonsurgical cannula (not shown) and directly to the surgical site. Thus,this method may be performed entirely without a cannulated guide. Inanother alternative, a cannulated guide, such as a drill guide, may beused with the drill to prepare the bone hole, but is then removed, alongwith the drill, once the bone hole 75 has been prepared. As mentionedabove, the preparation of the bone hole may occur prior to or subsequentto the passing of the filament around or through the tissue 80.

Alternatively, instead of cutting the remainder of the filament 20, oncethe anchor is positioned in bone, this length of filament may bemaneuvered to a second anchor, additional tissue, or the like, to beused in further securement of soft tissue as is required. For example,in an alternative embodiment, a method for the repair of a tissue, suchas a rotator cuff, may proceed largely as described above. However, oncethe anchor is secured in bone (as in FIG. 8K), at a medial position(such that the tissue may drape over the location of the bone hole 75),rather than cutting the remaining portion of the filament 20, thisportion is instead passed through the tissue, and passed over the tissuein a lateral direction, to a second bone hole positioned lateral to thereattachment footprint of the rotator cuff tissue. Once in thisposition, a second anchor, such as a ReelX STT suture anchor (StrykerEndoscopy, San Jose, Calif.), may be positioned on the filament and maybe used to secure the resulting suture bridge extending from the firstanchor to the second anchor.

The present invention also includes various alternative embodiments ofmethods for tissue repair utilizing the above-discussed devices. In someembodiments, the filament 20, 120 may be used on its own, without anchor10, or with another type of anchor, such as the above ReelX STT anchor(as in FIGS. 9A-C, below). As above, such alternative methods may beperformed without a cannulated guide, or the method may include the useof a cannulated guide for drilling the bone hole, or additionally forother steps. Such methods may also utilize a single filament 20, 120 ormultiple filaments 20, 120, in conjunction with one or more anchors ofvarious type.

In one alternative embodiment for tissue repair, such as the repair of atorn rotator cuff, for example, a first filament 20 may be secured tothe cuff at a first location using the “luggage tag” configuration. Thefirst end 21 of the filament may then be tensioned laterally to pull thetissue towards a first bone hole prepared laterally to the footprint ofthe rotator cuff tissue. The filament first end 21 may then be engagedby an anchor, such as the ReelX STT anchor, to secure the tissue.Furthermore, this method may include a second filament 20 which may besecured to the cuff at a second location, separate from the firstlocation, using the “luggage tag” configuration. The first end 21 of thesecond filament may then be tensioned laterally to pull the tissuetowards a second bone hole prepared laterally to the footprint of therotator cuff tissue. The first end 21 of the second filament may then beengaged by an anchor, such as the ReelX STT anchor, to secure thetissue. In an alternative, the first ends of both the first and secondfilaments may be tensioned laterally to a single bone hole and therebyengaged by a single anchor to secure the tissue.

In another embodiment, illustrated in FIGS. 9A-C, two filaments and twoseparate suture anchors, similar to those described in the previousembodiment, may be used to repair soft tissue, for example, rotator cufftissue 80. In this embodiment, however, filament 120, each having twodiscrete lengths of filament, or tails, are used (see FIG. 5). Theinitial steps of this embodiment are similar to those above. Namely,each filament 120, 120′ is passed through the cuff 80 at first andsecond locations 85 a, 85 b, respectively (see FIG. 9A), and securedthereto by passing the first end 121 a, 121 a′ of the first tail throughthe loop 123, 123′ (see FIG. 9B) to form the luggage tag configuration.At this position, the loop 123, 123′ and second end 122 a, 122 a′ of thefirst tail wrap around a portion of the cuff tissue such that,effectively, two strands (of each loop) are positioned on the topsurface of the tissue, and a single strand (the second end of each firststrand) is positioned on the bottom surface of the tissue, and the loopand first strand engage one another both at the edge of the tissue 80and at the first (or second) location 85 a. Such contact with the tissuemay provide a strong connection between the filament and tissue whichmay provide for an effective repair (e.g., decreases the risk of thefilament tearing the tissue). Of course, a portion of the loop may bepositioned on the bottom of the tissue (or conversely, a portion of thesecond end 122 a may be positioned on the top of the tissue) dependingon the position of the first (or second) location, the size of the loop123, or the like, though it is preferred that the loop be on the topsurface of the tissue and the single strand be on the bottom surface ofthe tissue.

Once the luggage tag is positioned on the tissue, the first ends 121 a,121 a′ are tensioned and positioned adjacent to lateral bone holes 75,75′ in bone 70, respectively, and are each engaged by an anchor, such asthe ReelX STT anchor, to secure the tissue. During the tensioning step,the tissue may be drawn laterally toward the bone holes. Of course, inanother configuration, the first ends 121 a, 121 a′ may be crossed suchthat, for example, first end 121 a is secured at bone hole 75′ and firstend 121 a′ is secured at bone hole 75.

Once the first tails (having first ends 121 a, 121 a′) are secured atbone holes 75, 75′, the second tails may then be manipulated by theoperator. These tails may be used to secure further tissue, may besecured to one another, or the like. In the illustrated exemplaryembodiment (see FIG. 9C), the two second tails are engaged by an anchor,such as the ReelX STT anchor, to secure the tissue at a third bone hole75″. Of course, this bone hole 75″ may be positioned anywhere desired.Again, using the illustrated example, the operator may tension thesecond tails by pulling first ends 121 b, 121 b′ laterally, towards bonehole 75″ to engage a bone anchor and secure the filaments to maintaintension.

As a result, as in FIG. 9C, an effectively double row suture bridgeconfiguration results which provides for a large footprint to maintainthe tissue against the bone surface. Additionally, as illustrated, onlytwo lengths of filament (second ends 122 a, 122 a′) are positionedbetween the tissue 80 and bone 70, which allows for direct contactbetween the tissue and bone along substantially the entire surface areaof the repair.

In another variation to this embodiment, an anchor 10 may be positionedunder tissue 80, and additionally, an anchor may be positionedunderneath both first and second positions 85 a, 85 b. Anchor 10, atthese positions, may engage the loops 123, 123′, or either tail atpositions 122 a and/or 122 b, and 122 a′ and/or 122 b′. The tails maythen be passed over the tissue 80 and to at least one lateral anchor asdiscussed above. Such variations may provide for additional securementof the soft tissue 80 to the bone 70.

In yet another embodiment, a method of repair of soft tissue may includethe use of a filament 120 and a first anchor 110, as illustrated inFIGS. 10A-B. Anchor 110 may be a standard suture anchor as is known inthe art. The anchor 110 is positioned in bone 70 under the soft tissue80, such as a rotator cuff, and one of the tails of filament 120 isengaged by the anchor. For example, the anchor may include an eyelet andthe tail of the filament may be passed through the eyelet. The filamenttail, such as tail having first end 121 a in FIG. 10A, which is engagingthe anchor, is passed through the tissue at a first location 185 a, andpositioned in a lateral direction relative to the tissue 80. The secondtail, including first end 121 b as in FIG. 10A, is also passed throughthe tissue at a second location 185 b and first end 121 b may bepositioned in a lateral direction relative to the tissue. As illustratedin FIG. 10A, as the second tail (ending in first end 121 b) is passedthrough the tissue, the loop 123 and the second end 122 a of the firsttail are also pulled through the tissue at location 185 b. Since thefilament freely slides through the eyelet, however, the location of theloop 123 may be adjusted to, for example, be adjacent to either of thefirst location 185 a, the second location 185, or any other location theoperator may desire.

Once the filament is positioned relative to the tissue, the first end121 a may be passed through loop 123 to form a luggage tag configurationbetween the first location 185 a and the second location 185 b, as shownin FIG. 10A. Further manipulation of first ends 121 a, 121 b may tensionthe luggage tag configuration such that loop 123 is pulled adjacent theouter surface of tissue 80, as in FIG. 10B. Once again, the operator mayposition loop 123 to be adjacent either the first location 185 a or thesecond location 185 b, or alternatively, as in FIG. 10B, the loop 123may be positioned over anchor 110 such that it is generally equidistantfrom the first and second locations 185 a, 185 b. The position of FIG.10B may be beneficial to assist the operator in creating an even repairalong the length of the tissue 80. With the loop 123 in position againsttissue 80, first ends 121 a, 121 b may be tensioned further in a lateraldirection towards a lateral bone hole 75′, and secured at bone hole 75′by a second anchor positioned therein. The tension applied to first andsecond ends 121 a, 121 b may tension the tissue 80 in the lateraldirection, as well as cause the loop 123 to migrate laterally. Suchlateral tension may return the tissue to a native footprint (as in theexample of a rotator cuff repair), or at least create desirable tensionon the tissue to form a reliable and beneficial repair.

As with the other method embodiments discussed above, this embodimentmay also include variations as to the number of filaments, number oftails on each filament, number of anchors, positioning of anchors, andthe like. For example, in one alternative, two medial anchors,positioned under the tissue 80, may be positioned such that a firstmedial anchor is at the first location 185 a and a second medial anchoris positioned at the second location 185 b. The tails (extending tofirst ends 121 a, 121 b), extending from the first and second locations185 a, 185 b, may then extend to a single lateral anchor, as discussedabove, or alternatively to two lateral anchors. In the alternative oftwo lateral anchors, the tails may, following passage through the loop123, extend in generally parallel fashion relative to one another fromthe first and second locations 185 a, 185 b to first and second lateralanchors, respectively. Alternatively, the first and second tails 121 a,121 b may be crossed such that the tail extending from the firstlocation 185 a may extend to the second lateral anchor and the tailextending from the second location 185 b may extend to the first lateralanchor.

A further exemplary variation is illustrated in FIGS. 11A-B. Thisembodiment includes a similar configuration as the embodiment of FIGS.10A-B above, with the exception that this embodiment includes twolateral bone holes 75′ and 75″. Thus, the initial steps of thisillustrative embodiment is identical to that of FIGS. 10A-10B above,except an additional lateral bone hole 75″ is prepared. In FIG. 11A, asin FIG. 10A above, the first end 121 a of the first tail is passedthrough loop 123 to create the luggage-tag configuration, and both firstends 121 a, 121 b of first and second tails are positioned laterallyrelative to the tissue 80 (in this example, rotator cuff tissue) andtowards bone holes 75′, 75″. As illustrated in FIG. 11B, the tissuerepair is made by tensioning first end 121 a of the first tail in thelateral direction. Such tension may also position the loop 123 laterally(FIG. 11B) as well as tension the tissue 80 laterally, though thefilament may be adjusted to position the filament anywhere between,effectively, the second location 185B and the bone hole 75′. Theoperator may then tension first end 121 a (while maintaining an amountof tension on the second tail, through first end 121 b, to maintain thepositioning of the loop 123) to tension the luggage tag configurationand create tension on the tissue 80 as desired. The operator may thensecure the first tail in bone holes 75′ using a suture anchor to securethe repair. Once the first tail is secured at bone hole 75′, the secondtail, having first end 121 b, may then be secured at bone hole 75″. Whensecuring the second tail, the operator may place any desired tension onthe second tail, such that the second tail may tension the loop, andpull it towards the second bone hole 75″, and may also impart additionaltension on the tissue 80. Alternatively, the tension on the first tailmay be only a moderate amount, sufficient to create a stable construct,and then the operator may use the second tail to impart the tension onthe loop 123, and thus the first tail and the tissue, to create areliable and beneficial repair.

In any of such methods using the devices of the present invention, theuse of filament 20, 120 provides for a stronger and more reliable repairof the soft tissue due to the absence of a knot along its length. Theloops 23, 123 of such filaments are a woven portion of the filament, andthus a knot is not required, thereby eliminating a weak point in thelength of the filament commonly found in other filament arrangementsutilizing a knot. Additionally, in those embodiments in which the loopand a portion of a tail are wrapped around the tissue in a “luggage tag”configuration, such a configuration provides for a stronger and morestable connection between the filament and the tissue than a simplepass-through of the suture, or a knot. Such a configuration,additionally, may decrease the likelihood of the tissue tearing, orother trauma, at the location of the suture passing through the tissue.

Although the invention herein has been described with reference toparticular embodiments, it is to be understood that these embodimentsare merely illustrative of the principles and applications of thepresent invention. It is therefore to be understood that numerousmodifications may be made to the illustrative embodiments and that otherarrangements may be devised without departing from the spirit and scopeof the present invention as defined by the appended claims.

1. (canceled)
 2. An anchor for securing tissue to bone, comprising: abody adapted to be inserted into a hole in a bone, the body having adistal end and a proximal end, wherein the distal end includes a saddledefining a distally oriented concavity open at the distal end of thebody, the saddle being adapted for engaging a loop of a filament bymoving the body towards the loop from a position remote from the loopuntil the loop is received within the saddle, wherein the body includesa cannulation extending longitudinally between the distal end and theproximal end of the body, the cannulation communicating with the saddle,and wherein the body has a first groove extending longitudinally alongan exterior surface of the body, the first groove extending proximallyfrom the saddle such that a distal end of the first groove communicateswith a proximal end of the concavity defined by the saddle.
 3. Theanchor of claim 2, wherein the body further includes a second grooveextending longitudinally along the exterior surface of the body.
 4. Theanchor of claim 2, wherein the body further includes at least one ridgeextending in a circumferential direction transverse to the first groove.5. The anchor of claim 2, wherein the distal end of the body includes afirst tip and a second tip, the first and second tips being opposed toone another on either side of the saddle.
 6. The anchor of claim 2,wherein the proximal end of the body includes an engagement structureadapted for engagement by an inserter instrument.
 7. A system forsecuring tissue to bone, comprising: the anchor of claim 6; and theinserter instrument, wherein the inserter instrument is adapted toengage the engagement structure of the anchor.
 8. A system for securingtissue to bone, comprising: the anchor of claim 2; and an inserterinstrument adapted to engage the anchor for positioning the anchorwithin a surgical site of a patient's body.
 9. The system of claim 8,wherein the inserter instrument includes a cannulation along at least aportion of its length.
 10. The system of claim 9, wherein the inserterinstrument includes an opening along a longitudinal side of the inserterinstrument, the opening communicating with the cannulation of theinserter.
 11. The system of claim 10, further comprising the filament,the filament having a first end and a second end, the second endincluding the loop, wherein a first portion of the filament at the firstend is stiffer than another portion of the filament, and wherein alength of the first portion of the filament is sufficient to span adistance between the distal end of the anchor and the opening along thelongitudinal side of the inserter instrument when the inserterinstrument is engaged with the anchor.
 12. The system of claim 8,wherein the inserter instrument includes an indicia positioned along theinserter instrument so as to indicate a minimum depth of insertion ofthe anchor into bone.
 13. The system of claim 8, wherein the inserterinstrument includes an indicia positioned along the inserter instrumentso as to indicate a maximum depth of insertion of the anchor into bone.14. A system for securing tissue to bone, comprising: the anchor ofclaim 2; and the filament having a first end and a second end, thesecond end including the loop; wherein the saddle and the cannulation ofthe anchor are adapted to receive the filament therein.
 15. The systemof claim 14, wherein the loop of the filament is formed without a knot.16. The system of claim 15, wherein the loop of the filament is formedby weaving portions of the filament together.
 17. The system of claim14, wherein a first portion of the filament at the first end is stifferthan another portion of the filament.
 18. A system for securing tissueto bone, comprising: the anchor of claim 2; and a drill.
 19. The systemof claim 18, wherein the drill comprises a boring structure having afirst portion and a second portion, the second portion being positionedproximal to the first portion, wherein the first portion has a firstdiameter and the second portion has a second diameter, the seconddiameter being larger than the first diameter such that a step isdefined between the first and second portions, and wherein a diameter ofthe anchor is larger than the first diameter.
 20. The system of claim18, wherein the drill further includes a stop surface extending radiallyoutwardly along an outer surface of the drill.
 21. The system of claim20, wherein the stop surface includes a marking material thereon.